Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
LDK · Predicate Candidate Screening
8 FDA 510(k) clearances under this product code; the 50 most recent screened below.
106 daysmedian FDA review time
631 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K230463 | NSite Scoliosis Assessment App | Nsite, Inc. | 2023-11-15 | 267 | 0 |
| K232023 | Momentum Spine | Momentum Health, Inc. | 2023-10-04 | 89 | 0 |
| K183485 | CryoVizion System | Cryos Technologies, Inc. | 2019-08-28 | 254 | 0 |
| K923792 | QUANTEC SPINAL MEASUEMENT SYSTEM | Quantec Image Processing , Ltd. | 1994-04-20 | 631 | 0 |
| K860225 | METRICOM | Far Orthopedics, Inc. | 1986-02-11 | 20 | 0 |
| K851133 | TERRAN BIOMECHANICAL ANALYSIS SYSTEM | Terran Biomedical Instruments | 1985-06-19 | 90 | 0 |
| K844736 | ISIS | Oxford Medilog, Inc. | 1985-03-21 | 106 | 0 |
| K800591 | CONTOUROGRAPH M-500 | Bio-Tek Instruments, Inc. | 1980-04-02 | 16 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda